Impaired Wound HealingMomelanMohsNCT01442844
Secondary Intention Wound Healing Versus Micrografting in Patients Undergoing Mohs Surgery
A study testing Micrografting in people with Impaired Wound Healing, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study evaluates a novel micrografting technique to see how it will influence the healing rate and cosmetic result of second intention wounds. The graft harvesting and micrografting process was designed by MoMelan Technologies The Epidermal Expansion System, which is composed of a commercially available Blister… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Impaired Wound Healing
- What is being tested?
- Micrografting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 40-75 years old
- Status post Mohs procedure on the scalp with a wound that would otherwise be allowed to heal by second intention
- Superficial would-at deepest of 2.0 mm or to superficial fat, but not deep to muscle
- Area is less then 6 cm2 (wound diameter less than 2cm)
Who cannot join
- Female patients who are breastfeeding, pregnant, or planning to become pregnant
- Abnormal bleeding observed during initial Mohs procedure that would suggest a higher risk of post-operative bleeding
- Subjects currently on immunosuppressive medications, chemotherapy or a cytotoxic agent
- Participation in another interventional study with potential exposure to an investigational drug within past 30 days or planned study entry within 90 days after study entrance
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates a novel micrografting technique to see how it will influence the healing rate and cosmetic result of second intention wounds. The graft harvesting and micrografting process was designed by MoMelan Technologies The Epidermal Expansion System, which is composed of a commercially available Blister Generation Device and the Microblister Generation and Excision Device (MBGED), will generate an array of small microblisters and transfer the micrografts to a sterile dressing (Tegaderm™ - an FDA approved wound dressing) for application to the subject's surgical area. The investigators predict that applying expanded micrografts to wounds that otherwise would have healed by second intention alone will hasten healing and possible reduce scarring.
Read the detailed description
Participants with a scalp wound s/p Mohs procedure will be randomized to a micrografting technique intervention or to no intervention/heal with secondary intention alone (control). Intervention consists of harvesting skin micrografts (1.75mm) from pigmented skin using the Microblister generation and excision device and transfer the micrografts to a sterile dressing for application to the participants scalp wound. Percent wound re-epithelialization will be compared between two groups.
- Conditions
- Impaired Wound Healing
- Being tested
- Micrografting
- Keywords
- Mohs, Scalp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrograftingDevice
Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.
| Study group | Role | What they receive |
|---|---|---|
| Micrografting | Active comparator | Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound. Receives: Device: Micrografting |
| No intervention | No intervention | No intervention will be performed. Subject will receive dressings that are standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Wound Re-epithelialization
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: The study sponsor was acquired by a company that focuses on chronic wounds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Impaired Wound HealingStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Momelan Technologies
- Responsible party
- Principal investigator, Alexandra Kimball, Massachusetts General Hospital
- Investigators
- Alexandra B Kimball, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442844
- Sponsor's protocol ID
- 2010p002614
- Acronym
- MomelanMohs
- Status last verified
- Jun 2014
- First submitted
- 27 Sep 2011
- Last updated
- 17 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Intention Wound Healing Versus Micrografting in Patients Undergoing Mohs Surgery
- ClinicalTrials.gov ID
- NCT01442844
- Acronym / sponsor ID
- MomelanMohs / 2010p002614
- Conditions
- Impaired Wound Healing
- Keywords
- Mohs, Scalp
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study sponsor was acquired by a company that focuses on chronic wounds
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Momelan Technologies
- Study start
- Sep 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 29 Sep 2011 (estimated)
- Results
- Posted 17 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates a novel micrografting technique to see how it will influence the healing rate and cosmetic result of second intention wounds. The graft harvesting and micrografting process was designed by MoMelan Technologies The Epidermal Expansion System, which is composed of a commercially available Blister Generation Device and the Microblister Generation and Excision Device (MBGED), will generate an array of small microblisters and transfer the micrografts to a sterile dressing (Tegaderm™ - an FDA approved wound dressing) for application to the subject's surgical area. The investigators predict that applying expanded micrografts to wounds that otherwise would have healed by second intention alone will hasten healing and possible reduce scarring.
Detailed description
Participants with a scalp wound s/p Mohs procedure will be randomized to a micrografting technique intervention or to no intervention/heal with secondary intention alone (control). Intervention consists of harvesting skin micrografts (1.75mm) from pigmented skin using the Microblister generation and excision device and transfer the micrografts to a sterile dressing for application to the participants scalp wound. Percent wound re-epithelialization will be compared between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micrografting | Active comparator | Device: MicrograftingSeveral small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound. |
| No intervention | No intervention | –No intervention will be performed. Subject will receive dressings that are standard of care. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between 40-75 years old
- Status post Mohs procedure on the scalp with a wound that would otherwise be allowed to heal by second intention
- Superficial would-at deepest of 2.0 mm or to superficial fat, but not deep to muscle
- Area is less then 6 cm2 (wound diameter less than 2cm)
Key exclusion criteria (4 listed)
- Female patients who are breastfeeding, pregnant, or planning to become pregnant
- Abnormal bleeding observed during initial Mohs procedure that would suggest a higher risk of post-operative bleeding
- Subjects currently on immunosuppressive medications, chemotherapy or a cytotoxic agent
- Participation in another interventional study with potential exposure to an investigational drug within past 30 days or planned study entry within 90 days after study entrance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicrograftingSeveral small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound. | Device | Micrografting |
Primary outcome
Percentage of Wound Re-epithelialization
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra B Kimball, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micrografting in people with Impaired Wound Healing, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Wound Re-epithelialization (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2014.